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Generated: April 26, 2017

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Details for New Drug Application (NDA): 022369

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NDA 022369 describes LATISSE, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LATISSE profile page.

The generic ingredient in LATISSE is bimatoprost. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the bimatoprost profile page.

Summary for NDA: 022369

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 022369

Ingredient-typeProstaglandins

Suppliers and Packaging for NDA: 022369

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATISSE
bimatoprost
SOLUTION/DROPS;TOPICAL 022369 NDA Allergan, Inc. 0023-3616 0023-3616-03 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-03) > 3 mL in 1 BOTTLE, DROPPER
LATISSE
bimatoprost
SOLUTION/DROPS;TOPICAL 022369 NDA Allergan, Inc. 0023-3616 0023-3616-04 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-04) > 3 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;TOPICALStrength0.03%
Approval Date:Dec 24, 2008TE:ATRLD:Yes
Patent:9,579,270Patent Expiration:Jan 31, 2021Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 4, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA, AND ADOLESCENTS WHO HAD HYPERTRICHOSIS WITH NO ASSOCIATED MEDICAL CONDITION
Patent:8,632,760Patent Expiration:Jan 15, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF INCREASING EYELASH GROWTH

Expired Orange Book Patents for NDA: 022369

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
LATISSE
bimatoprost
SOLUTION/DROPS;TOPICAL022369-001Dec 24, 20086,403,649► Subscribe
Allergan
LATISSE
bimatoprost
SOLUTION/DROPS;TOPICAL022369-001Dec 24, 20088,017,655► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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